MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL LRS PLATELET,SAMPLER, AUTOPAS, PLASMA, RBC

Catalog Number 82420

Device Problems High Test Results (2457); Adverse Event Without Identified Device or Use Problem (2993); Data Problem (3196)

Patient Problem No Patient Involvement (2645)

Event Date 06/03/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation : the run data file (rdf) was analyzed for this event.Alerts that could contribute to wbc contamination of the platelet product, such as ¿centrifuge pressure high¿ or ¿rbc spillover¿, were not generated in the run data file analyzed.As the rbc detector cannot count the cells passing by, in order to generate a ¿potential wbc contamination detected¿ message,the rbc detector signals must see a significant change in the reflectance values.In this case, rbc detector reflectance signals did not indicate that wbcs were escaping the lrs chamber.Therefore, the run data file reported that the platelet product could be labeled as leukoreduced.Run data file analysis showed that frequent ¿return pressure too high¿ and ¿draw pressure too low¿ alerts were generated during this procedure.In response to these alerts, the operator made multiple draw and return flow adjustments.These adjustments reduced the inlet flow, and therefore the flow through the lrs chamber.When the flow through the lrs chamber is greatly reduced, the risks of wbc contamination are increased.While the trima accel system is typically robust against numerous flow alerts and adjustments, it is possible that the high number of alerts and adjustments that occurred during short periods throughout the procedure could have disrupted the steady-state of the system and contributed to the igher-than-expected wbc content in the platelet product.Based on the available information, it is also possible that this leukoreduction failure could be donor-related.Investigation is in process.A follow-up report will be provided.

Event Description

The customer would like the run data file investigated to determine a possible cause for the elevated white blood cell (wbc) content in the platelet product.There was not a transfusion recipient or patient involved at the time of the residual white blood cell (rwbc) testing, therefore no patient information is reasonably known at the time of the event.The platelet collection set is not available for return because it was discarded by the customer.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Manufacturer Narrative

This report is being filed to provide additional information and corrected information.Investigation: the device history records (dhr) were reviewed for this lot.There were no events noted in the dhr that would have contributed to the elevated wbc count experienced by the customer.Root cause: alerts that could contribute to wbc contamination of the platelet product, such as¿centrifuge pressure high¿ or ¿rbc spillover¿, were not generated in the run data file analyzed.As the rbc detector cannot count the cells passing by, in order to generate a ¿potential wbc contamination detected¿ message, the rbc detector signals must see a significant change in the reflectance values.In this case, rbc detector reflectance signals did not indicate that wbcs were escaping the lrs chamber.Therefore, the run data file reported that the platelet product could be labeled as leukoreduced.Run data file analysis showed that frequent ¿return pressure too high¿ and ¿draw pressure too low¿ alerts were generated during this procedure.In response to these alerts, the operator made multiple draw and return flow adjustments.These adjustments reduced the inlet flow, and therefore the flow through the lrs chamber.When the flow through the lrs chamber is greatly reduced, the risks of wbc contamination are increased.While the trima accel automated blood collection system is typically robust against numerous flow alerts and adjustments, it is possible that the high number of alerts and adjustments that occurred during short periods throughout the procedure could have disrupted the steady-state of the system and contributed to the higher-than-expected wbc content in the platelet product.Based on the available information, it is also possible that this leukoreduction failure could be donor-related.

Event Description

Donation id: (b)(4).

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET,SAMPLER, AUTOPAS, PLASMA, RBC
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w.collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 7645978
• MDR Text Key: 113173127
• Report Number: 1722028-2018-00184
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2019
• Device Catalogue Number: 82420
• Device Lot Number: 1708151330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 06/05/2018
• Initial Date FDA Received: 06/28/2018
• Supplement Dates Manufacturer Received: 07/11/2018
• Supplement Dates FDA Received: 07/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other